Bone Marrow Aspiration and Biopsy Specimen CollectionNCT02159118
A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children
A study testing Manual bone marrow aspiration and biopsy device and Powered bone marrow aspiration and biopsy device in people with Bone Marrow Aspiration and Biopsy Specimen Collection, run by Vidacare Corporation at 1 site in United States.
Trial summary
The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Bone Marrow Aspiration and Biopsy Specimen Collection
- What is being tested?
- Manual bone marrow aspiration and biopsy device and Powered bone marrow aspiration and biopsy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent and assent for minors over the age of seven years must be obtained before any trial-related activities are initiated
- Patients requiring bone marrow aspirations and/or biopsies as part of standard diagnosis and treatment
- Treated at Christus Santa Rosa Children's hospital
- Age 2 to 18 years
- Male or female
- Supportive family with willingness to participate in completing questionnaires
- English or Spanish primary language
Who cannot join
- Patients who are pregnant
- Patients with hemorrhagic disorders such as congenital coagulation factor deficiencies disseminated intravascular coagulation and concomitant use of anticoagulants
- Patients with a skin infection or recent radiation therapy at the sampling site
- Patients with bone disorders such as osteomyelitis or osteogenesis imperfecta
Trial locations and contacts
1 site in 1 country.
United States1 site
Christus Santa Rosa Children's Hospital
San Antonio, Texas, 78207
About this study
Official title: A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children
The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.
Read the detailed description
The purpose of this randomized, prospective trial is to compare use of the standard manual bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.
- Being tested
- Manual bone marrow aspiration and biopsy device, Powered bone marrow aspiration and biopsy device
- Keywords
- bone marrow aspiration, bone marrow biopsy, OnControl, powered bone marrow aspiration and biopsy device, standard manual bone marrow aspiration and biopsy device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual bone marrow aspiration and biopsy deviceDevice
Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.
Powered bone marrow aspiration and biopsy deviceDevice
Also called OnControl
Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.
| Study group | Role | What they receive |
|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Active comparator | Manual bone marrow aspiration and biopsy device Receives: Device: Manual bone marrow aspiration and biopsy device |
| Powered bone marrow aspiration and biopsy procedure | Active comparator | Powered bone marrow aspiration and biopsy device Receives: Device: Powered bone marrow aspiration and biopsy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.
Measured: within 24 hours of bone marrow sampling procedure
Secondary outcomes (8)
Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.
Measured: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.
Measured: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume
Measured: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device
number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device
Measured: at time of the bone marrow sampling procedure
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device
measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.
Measured: at time of the bone marrow sampling procedure
Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device
Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.
Measured: within 4 hours of the bone marrow sampling procedure
Operator Satisfaction With Manual Device and Powered Device
Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.
Measured: Within 24 hours of the bone marrow sampling procedure
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device
measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.
Measured: at time of the bone marrow sampling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Marrow Aspiration and Biopsy Specimen CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Chatchawin Assanasen, MD, The University of Texas Health Science Center at San Antonio
- Investigators
- Chatchawin Assanasen, MD, Principal investigator, Christus Santa Rosa Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159118
- Sponsor's protocol ID
- 2012
- Status last verified
- Aug 2014
- First submitted
- 15 May 2014
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children
- ClinicalTrials.gov ID
- NCT02159118
- Acronym / sponsor ID
- 2012
- Keywords
- bone marrow aspiration, bone marrow biopsy, OnControl, powered bone marrow aspiration and biopsy device, standard manual bone marrow aspiration and biopsy device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.
Detailed description
The purpose of this randomized, prospective trial is to compare use of the standard manual bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual bone marrow aspiration and biopsy procedure | Active comparator | Device: Manual bone marrow aspiration and biopsy deviceManual bone marrow aspiration and biopsy device |
| Powered bone marrow aspiration and biopsy procedure | Active comparator | Device: Powered bone marrow aspiration and biopsy devicePowered bone marrow aspiration and biopsy device |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Informed consent and assent for minors over the age of seven years must be obtained before any trial-related activities are initiated
- Patients requiring bone marrow aspirations and/or biopsies as part of standard diagnosis and treatment
- Treated at Christus Santa Rosa Children's hospital
- Age 2 to 18 years
- Male or female
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Patients with hemorrhagic disorders such as congenital coagulation factor deficiencies disseminated intravascular coagulation and concomitant use of anticoagulants
- Patients with a skin infection or recent radiation therapy at the sampling site
- Patients with bone disorders such as osteomyelitis or osteogenesis imperfecta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual bone marrow aspiration and biopsy deviceUse of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens. | Device | Manual bone marrow aspiration and biopsy procedure |
| Powered bone marrow aspiration and biopsy deviceAlso: OnControlUse of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens. | Device | Powered bone marrow aspiration and biopsy procedure |
Primary outcome
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
Time frame: within 24 hours of bone marrow sampling procedure
Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.
8 secondary outcomes
Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device
Time frame: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device
Time frame: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device
Time frame: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device
Time frame: at time of the bone marrow sampling procedure
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device
Time frame: at time of the bone marrow sampling procedure
Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device
Time frame: within 4 hours of the bone marrow sampling procedure
Operator Satisfaction With Manual Device and Powered Device
Time frame: Within 24 hours of the bone marrow sampling procedure
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device
Time frame: at time of the bone marrow sampling procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chatchawin Assanasen, MD principal investigator
Christus Santa Rosa Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual bone marrow aspiration and biopsy device and Powered bone marrow aspiration and biopsy device in people with Bone Marrow Aspiration and Biopsy Specimen Collection, run by Vidacare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device (time frame: within 24 hours of bone marrow sampling procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.